Registration Dossier
Registration Dossier
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EC number: 259-393-4 | CAS number: 54914-37-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-29 to 1985-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- EC Number:
- 259-393-4
- EC Name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- Cas Number:
- 54914-37-3
- Molecular formula:
- C18H34N2
- IUPAC Name:
- 1,3,3-Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethanamine
- Test material form:
- other: liquid
- Details on test material:
- Produced October 1980. Purity 95 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- - Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male and female
- Weight at study initiation: 2.0 - 2.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- Postexposure observation period: 12 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after (see exposure time)
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 5, 7, 9, and 12 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: according to scoring system
- Score:
- 18.21
- Max. score:
- 110
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: REVERSIBILITY: complete in 12 days except for alopecia on the margin of the lower eyelid of one animal
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.72
- Iris: 0.33
- Conjunctivae (Redness): 2.06
- Conjunctivae (Chemosis): 0.61
- Overall irritation score: 18.21/110
DESCRIPTION OF LESIONS: transient reddening of parts of the iris in the females
REVERSIBILITY: complete in 12 days except for alopecia on the margin of the lower eyelid of one animal
Applicant's summary and conclusion
- Conclusions:
- The crosslinking agent
1,3,3 -trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine
(VESTAMIN A 139), tested with one undiluted administration of 0,1 m3 to eyes or eyelid sac of male and female rabbits showed slightly irritating effects (OECD 405, 1981). - Executive summary:
The test substance tested with one undiluted administration of 0,1 m3to eyes or eyelid sac of male and female rabbits showed slightly irritating effects (OECD 405, 1981).
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